A Long-term Study to Evaluate the Efficacy and Safety of AK102 in Combination With Lipid-lowering Therapy in Patients With Hypercholesterolemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 796
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52
研究概览
简要总结
This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Body weight ≥ 40 kg for both men and women.
- •Participated in the AK102-202 study, and completed the AK102-202 study last visit.
排除标准
- •Poor compliance in AK102-202 study per investigator's judgement.
- •AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period.
- •Prior use of PCSK9 inhibitors other than AK102.
研究组 & 干预措施
AK102
450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
干预措施: 150mg AK102 (Drug)
AK102
450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
干预措施: 450mg AK102 (Drug)
AK102
450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
干预措施: 300mg AK102 (Drug)
AK102
450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection;
干预措施: Statins and/or Ezetimibe (Drug)
结局指标
主要结局
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52
时间窗: Week 52
次要结局
- Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0(From baseline through 52 weeks)
- Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol(From baseline through 52 weeks)
- Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)(From baseline through 52 weeks)
- Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)(From baseline through 52 weeks)
- Concentrations of AK102 in Serum(From baseline through 52 weeks)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From baseline through 52 weeks)
- Percent Change From Baseline in Apolipoprotein B (Apo B)(From baseline through 52 weeks)
- Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol(From baseline through 52 weeks)
- Percent Change From Baseline in Serum Triglyceride (TG) cholesterol(From baseline through 52 weeks)
- Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)(From baseline through 52 weeks)